A CDA, also known as Non-Disclosure Agreement, is an agreement between the University
and an outside entity (company or person) to facilitate discussions of confidential
information. For companies, sharing information about their proprietary drugs, protocol,
and other research and business developments can lead to research opportunities and
relationships with University personnel; however, the company would not want such
confidential information revealed to their competitors.

What we Need to Review a Clinical Research CDA

If you have a CDA that needs to be reviewed, please send the following items to a
Staff Specialist:

An editable version of the CDA or let us know if you would like us to request an editable
version from the sponsoring agency

Contact information for the PI and department

Contact information for the sponsor

Upon receipt of a Document Summary Sheet (DSS), we will assist with drafting, review,
negotiation and execution. Even though an agreement may be entered into in relation
to an individual area (e.g. PI, college, institute), it is ultimately a University
agreement and should only be signed by a University authorized official. Once we have this material, OSP will review and respond to the sponsor within 5
business days.

The Importance of Clinical Research CDA Review

For the University, maintaining confidentiality can preserve the University's rights
while ensuring compliance with all applicable laws and University policies. OSP has
been charged with reviewing, approving, and executing all CDA's for clinical research
at the University. The University's confidential obligations should always be subject
to other legal and practical considerations. Some of the issues OSP can assist you
with include:

The University's duty to disclose records in compliance with GRAMA (open records law),
and whether any third parties will need access to information (e.g., other vendors
[system integration], consultants or subcontractors, etc.)

The types of information that need to be exchanged to facilitate the business discussion
or services and determining whether the definition of "confidential information" accurately
reflects that understanding

How "confidential" information will be identified

How long information needs to be protected

Whether or not to return or destroy confidential information once the relationship
ends and whether to retain copies for archival/audit purposes